Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03170557 |
| Other study ID # |
CE-17017 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2017 |
| Est. completion date |
February 25, 2019 |
Study information
| Verified date |
August 2022 |
| Source |
Montecatone Rehabilitation Institute S.p.A. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pain is one of the most common problems in patients with spinal cord injury (SCI) and
persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often
poorly responsive to pharmacological therapy. Attention has been paid to the use of
non-pharmacological therapies and interventional techniques in treating pain in other
clinical conditions, and acupuncture has been the treatment most used and appreciated for its
effectiveness. However, only few studies are available on the use of acupuncture in SCI
patients. The present randomized, comparative trial aims to clarify the efficacy of
traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in
subjects with spinal cord injury, by overcoming the biases reported in previous studies.
Description:
About 67% of patients with spinal cord injury (SCI) experience painful symptoms in the course
of life after injury and a third evaluates the pain as "severe", with a significant impact on
quality of life, due to limitations in daily activities and autonomy. Persistent pain can be
of different origin and may be nociceptive, neuropathic or mixed. However, it is often poorly
responsive to pharmacological therapy. For some years, attention has been paid to the use of
non-pharmacological therapies and interventional techniques in treating pain, and acupuncture
has been the treatment most used and appreciated for its effectiveness. Only two studies on
the use of acupuncture in SCI patients were included in the only Cochrane review available,
dated 2014. Such studies, focusing on the painful shoulder syndrome and, therefore, on
skeletal muscle pain, show a "non-superiority" of acupuncture compared to sham acupuncture
treatment or Trager approach. However, the review does not come to any clear conclusions on
the effectiveness of intervention because of the small number of cases and high risk of bias.
A more recent primary, randomized, controlled trial on SCI patients, although focusing on
chronic pain and on a single acupuncture technique, uses a questionable study design
(cross-over) to demonstrate treatment efficacy.
The present randomized, comparative trial aims to clarify the efficacy of traditional
acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects
with spinal cord injury, by overcoming the biases reported in previous studies. Because of
the intrinsic effects of sham acupuncture and, generally, of skin stimulation, a
statistically significant change in the Numerical Rating Scale (NRS) measurements is expected
even in the comparison group. To minimize this bias, which cannot be avoided, and to maintain
the blindness of the patient as much as possible, the comparison group is treated by the
insertion of needles in skin areas outside the metamer(s) affected by pain.
Primary objective:
- To evaluate the efficacy of traditional acupuncture vs. aspecific needle skin stimulation
for persistent pain in subjects with spinal cord injury, at the end of treatment and at the 3
week follow-up.
Secondary objectives:
- Reduction of drug intake, at the end of treatment and at the subsequent follow-up;
- Reduction of anxiety/depression, at the end of treatment and at the subsequent
follow-up;
- Improvement of quality of life, at the end of treatment and at the subsequent follow-up;
- Persistence of the effect of acupuncture 9 weeks after treatment.
Data concerning any adverse events, related to both experimental treatments of the trial,
will also be collected.
